Xifaxan

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Xifaxan (Normix 200 mg), 200 mg, film-coated tablets
Rifaximin
Xifaxan and Normix 200 mg are different trade names for the same medicine.

Important

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Xifaxan and what is it used for
• 2. Important information before taking Xifaxan
• 3. How to take Xifaxan
• 4. Possible side effects
• 5. How to store Xifaxan
• 6. Contents of the pack and other information

1. What is Xifaxan and what is it used for

Xifaxan is an oral antibacterial medicine. It contains rifaximin, an antibiotic from the class of rifamycin antibiotics, but unlike other rifamycins, it is only slightly absorbed into the bloodstream from the gut (the α polymorphic form is absorbed at less than 1% of the administered dose), so it only acts on microorganisms in the gut. Xifaxan is active against most bacteria responsible for intestinal infections.

Indications

In adults and children over 12 years old

• intestinal infections with bacteria sensitive to rifaximin, exceptfor diarrhea with fever and/or blood in the stool and also when the number of unformed stools is equal to or exceeds 8 per day
• traveler's diarrhea, exceptfor diarrhea with fever and/or blood in the stool and also when the number of unformed stools is equal to or exceeds 8 per day,

In adults:

• hepatic encephalopathy,
• symptomatic, uncomplicated diverticular disease of the colon in adult patients on a high-fiber diet.

2. Important information before taking Xifaxan

When not to take Xifaxan:

• if the patient is allergic to rifaximin or other rifamycins or any of the other ingredients of this medicine (listed in section 6).
• if the patient has intestinal obstruction, even partial (intestinal blockage that prevents the passage of food through the intestines) and severe ulcerative intestinal damage.

Warnings and precautions

Before starting treatment, discuss the following issues with your doctor

• if the patient has diarrhea with fever or blood in the stool, or frequent bowel movements (8 times or more per day) - such symptoms are usually a sign of significant involvement of the intestinal mucosa by invasive intestinal pathogens (such as Campylobacter, Salmonella, and Shigella) and Xifaxan, with minimal absorption in the gastrointestinal tract, was not effective in these cases and therefore should not be used
• if renal impairment has been diagnosed in the patient, as there are no studies in this patient group
• in patients with liver cirrhosis (a type of liver disease), a severe skin reaction may occur, which can be life-threatening, with painful rash or blistering on the skin, mouth, eyes, and genitals. If a severe skin reaction or other hypersensitivity reaction occurs, the medicine should be discontinued immediately and a doctor consulted.

If the symptoms of diarrhea worsen or persist for more than 24-48 hours, Xifaxan should be discontinued, and the doctor will consider alternative therapy.
Diarrhea caused by Clostridium difficileinfection (causing a disease called pseudomembranous colitis) has been reported with the use of almost all antibacterial medicines. The most common symptoms of this infection are frequent, watery stools, sometimes with blood, severe abdominal cramps or pain, and fever. A potential link between rifaximin treatment and the occurrence of this infection cannot be ruled out. If symptoms of this disease occur, a doctor should be consulted.
A doctor should be consulted if a reddish discoloration of the urine is noticed after taking Xifaxan. This is caused by the active substance, which, like most antibiotics in the same family (rifamycins), has a reddish-orange color.

Children

Xifaxan should not be given to children under 12 years old.

Xifaxan and other medicines

Tell your doctor about all medicines taken recently, even those that are available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines: another rifamycin antibiotic for the treatment of systemic bacterial infections, warfarin, antiepileptic drugs, antiarrhythmic drugs, and cyclosporine.
When taking activated charcoal, Xifaxan should be taken at least 2 hours after charcoal.
In patients treated with warfarin who have been prescribed Xifaxan at the same time, cases of both decreased and increased international normalized ratio (INR) values have been observed. If concomitant administration of both medicines is necessary, INR should be carefully monitored at the start and end of Xifaxan treatment. The doctor may consider it necessary to adjust the dose of oral anticoagulant medicines belonging to the group of vitamin K antagonists.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if pregnancy is suspected, or if you are planning to become pregnant, consult your doctor before taking this medicine.
As a precaution, it is recommended to avoid using rifaximin during pregnancy.
In the case of Xifaxan use in breastfeeding women, the doctor will discuss with the patient whether to stop breastfeeding or discontinue Xifaxan treatment.
Animal studies have not shown any direct or indirect harmful effects on fertility in males and females.

Driving and using machines

The effect of Xifaxan on the ability to drive and use machines is negligible.
Caution should be exercised, and if symptoms such as dizziness, double vision, or drowsiness occur, you should not drive or operate machinery.
Xifaxan contains less than 1 mmol (23 mg) of sodium per 2 tablets, which means the medicine is considered "sodium-free".

3. How to take Xifaxan

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Xifaxan is:
Intestinal infections with bacteria sensitive to rifaximin:
Patients over 12 years old: 200 mg (1 tablet) every 8 hours to 400 mg (2 tablets) every 8-12 hours
Traveler's diarrhea:
Patients over 12 years old: 200 mg (1 tablet) every 8 hours for 3 days. Do not take for more than 3 days. Do not restart therapy if symptoms of diarrhea return after a short period of recovery (see "Warnings and precautions").
Hepatic encephalopathy:
Adult patients: 400 mg (2 tablets) every 8 hours.
Treatment should not last longer than 7 days.
Symptomatic uncomplicated diverticular disease of the colon
Adult patients on a high-fiber diet: 400 mg (2 tablets of 200 mg) every 12 hours for 7 days. If necessary, the doctor will recommend repeating the therapy every month for the next 11 months, i.e., a maximum of 12 cycles of 7 days. After complete disappearance of symptoms, the administration of the medicine should be discontinued.
A single treatment period with rifaximin should not be longer than 7 days.
Each re-initiation of rifaximin treatment should be preceded by a 30-day period without taking the medicine. If worsening or recurrence of symptoms occurs during this period, the patient should contact their doctor immediately.
Patients with renal impairment: although dose adjustment is not recommended, caution should be exercised in this patient group.
Patients with hepatic impairment: no dose adjustment is necessary in this patient group.
Elderly patients: no dose adjustment is required, as the data on safety and efficacy of Xifaxan did not show any differences between elderly and younger patients.
Children: the efficacy and safety of rifaximin have not been established in children under 12 years old.
Method of administration
The medicine can be taken with or without food. Take orally, with a glass of water.

Overdose of Xifaxan

If you have taken more than the recommended dose of Xifaxan, consult your doctor or pharmacist immediately.
If possible, take Xifaxan (the medicine and packaging) with you to show to your doctor or pharmacist.

Missed dose of Xifaxan

If you miss a dose, take it as soon as possible.
However, if it is almost time for your next dose, do not take the missed dose, but take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.

4. Possible side effects

Like all medicines, Xifaxan can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience:

any of the following:

• fever or severe generalized allergic reaction usually involving: cardiovascular system, lungs, skin (anaphylactoid reaction), allergic reaction with skin swelling (dermatitis, exfoliative dermatitis, eczema, rash, erythema, pruritus, urticaria) and (or) mucous membranes (angioedema), anaphylactoid syndrome
• life-threatening reaction with flu-like symptoms and painful rash on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)*
• life-threatening reaction with flu-like symptoms and blistering on the skin, mouth, eyes, and genitals*. *These reactions have been observed in patients with liver cirrhosis. See also "Warnings and precautions" in section 2.

Common side effects (affect 1 to 10 patients in 100): upper abdominal pain, constipation, sudden need to defecate, diarrhea, bloating with gas, increased abdominal tension, nausea, painful defecation, vomiting, fever, headache, dizziness.
Uncommon side effects (affect 1 to 10 patients in 1000): upper abdominal pain, fluid in the abdominal cavity (ascites), dyspepsia, dry mouth, disorders of food transport in the intestines, blood in the stool, hard stools, stools with mucus, taste disorders, abnormal blood test results (increased white blood cell count, i.e., lymphocytes, increased monocyte count, decreased neutrophil count), palpitations, dizziness, ear pain, double vision, weakness, pain and discomfort, chills, cold sweats, excessive sweating, flu-like illness, swelling of the legs and (or) arms, increased aspartate aminotransferase activity, thrush (candidiasis), vaginal yeast infection, Herpes simplex, rhinitis, pharyngitis, upper respiratory tract infections, decreased appetite, dehydration, back pain, muscle spasms, muscle weakness, neck pain, paresthesia (sensory disturbances), migraine, tingling in the limbs, sinusitis, drowsiness, sleep disorders, low mood, insomnia, nervousness, blood in the urine, sugar in the urine, frequent urination, excessive urination, protein in the urine, excessive menstrual bleeding, cough, dry throat, shortness of breath (dyspnea), stuffy nose, sore throat and larynx, runny nose, skin rashes, skin eruptions, exanthema (skin changes), photoallergic reactions, sudden flushing of the face, increased blood pressure.
Frequency not known (frequency cannot be estimated from the available data):
abnormal blood test results (decreased platelet count, abnormal liver function tests, disorders of international normalized ratio), infections with Clostridiumbacteria (C. difficile), anaphylactic reactions, hypersensitivity, anaphylactoid syndrome, angioedema (allergic reaction with skin and (or) mucous membrane swelling), dermatitis, exfoliative dermatitis, eczema, rash, erythema, pruritus, urticaria.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xifaxan

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage.
Do not use Xifaxan after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Xifaxan contains

• The active substance of Xifaxan is rifaximin. One film-coated tablet contains 200 mg of rifaximin.
• The other ingredients of the medicine are: Tablet core:sodium carboxymethylcellulose (type A), glycerol distearate, silica colloidal anhydrous, talc, microcrystalline cellulose. Coating:hypromellose, titanium dioxide (E 171), disodium edetate, propylene glycol, iron oxide red (E 172).

What Xifaxan looks like and contents of the pack

Xifaxan is a medicine in the form of pink, round, biconvex film-coated tablets.
Xifaxan tablets are packaged in PVC-PE-PVDC/Aluminum blisters in a cardboard box.
A pack of 12 tablets contains: 1 blister packaged in a cardboard box.
A pack of 24 tablets contains: 2 blisters packaged in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, the country of export:

Alfasigma S.p.A.
Via Ragazzi del ‘99, n. 5
40133 Bologna (BO), Italy

Manufacturer:

Alfasigma S.p.A.
Via Pontina Km 30,400
00071 Pomezia (RM), Italy
Alfasigma S.p.A.,
Via E. Fermi, n. 1
65020 Alanno (PE), Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Italy, the country of export:025300029
Parallel import authorization number:65/19

Date of leaflet approval: 12.02.2024

[Information about the trademark]